Ex Parte Pugh et al

Patent Trial and Appeal Board

Feb 19, 2016

13812604 (P.T.A.B. Feb. 19, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/812,604 03/08/2013 Coleen Pugh
26360 7590 02/19/2016
Renner Kenner Greive Bobak Taylor & Weber Co., LPA
First National Tower, Suite 400
106 South Main Street
Akron, OH 44308-1412
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
UOA.810.US 5186
EXAMINER
BOYLE, ROBERT C
ART UNIT PAPER NUMBER
1764
MAILDATE DELIVERY MODE
02/19/2016 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte COLEEN PUGH, ABHISHEK BANERJEE,
WILLIAM STORMS, and COLIN WRIGHT
Appeal2014-009304
Application 13/812,604
Technology Center 1700
Before CHUNG K. PAK, JEFFREY T. SMITH, and
WESLEY B. DERRICK, Administrative Patent Judges.
PAK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 appeal under 35 U.S.C. § 134(a) from the Examiner's
decision finally rejecting claims 1 through 7, 16, and 17. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
The subject matter on appeal is directed to a functionalized, random,
biodegradable copolyester comprising (I) repeat units derived from (A) one
or more diols containing from 2 to about 10 carbon atoms and one or more
1 Appellants identify the Real Party in Interest as The University of Akron
(Appeal Brief filed May 27, 2014 ("App. Br.") at 1.)
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Application 13/812,604
dicarboxylic acids containing from 2 to about 15 carbon atoms; (B) one or
more hydroxyacids containing from 2 to about 20 carbon atoms; or (C) both
one or more diols containing from 2 to about 10 carbon atoms and one or
more dicarboxylic acids containing from 2 to about 15 carbon atoms, and
one or more hydroxyacids containing from 2 to about 20 carbon atoms; and
(II) repeat units derived from one or more (A) a-halogenated hydroxyacids,
or (B) a -halogenated hydroxyalkonoate esters. (Spec. i-f 13.)
Details of the appealed subject matter are recited in representative
claim 1 2 reproduced below from the Claims Appendix to the Appeal Brief.
1. A functionalized biodegradable copolyester, comprising;
repeat units derived from one or more diols containing from 2
to about 10 carbon atoms and one or more dicarboxylic acids
containing from 2 to about 15 carbon atoms, or repeat units
derived from one or more hydroxyacids containing from 2 to
about 20 carbon atoms, or both; functionalized repeat units
derived from one or more a-halogenated hydroxyacids or a-
halogenated hydroxyalkonoate [sic] esters; and wherein said
copolyester is a random, statistical copolymer and is
biodegradable.
(App. Br. 10, Claims App'x.)
Appellants seek review of the following grounds of rejection
maintained by the Examiner in the Answer mailed on June 17, 2014
("Ans."):
2 Appellants argue claims 1-7, 16, and 17 as a group. (See generally App.
Br. 3-8.) Therefore, for the purposes of this appeal, we select claim 1 as
representative and decide the propriety of the rejections of record based on
this claim alone. 37 C.F.R. § 41.37(c)(l)(iv).
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1. Claims 1, 16, and 17 under 35 U.S.C. § 103(a) as unpatentable
over the disclosure of U.S. Patent 6,245,537 Bl issued in the name of
Williams et al. on June 12, 2001 (hereinafter referred to as "Williams"); and
2. Claims 1-7, 16, and 17 under 35 U.S.C. § 103(a) as
unpatentable over the disclosure of European Patent Application Publication
EP 0052459 Al published in the name of Holmes et al. on May 26, 1982
(hereinafter referred to as "Holmes").
DISCUSSION
Upon consideration of the evidence on this record and each of
Appellants' contentions, we find that a preponderance of the evidence
supports the Examiner's determination that one of ordinary skill in the art,
armed with the knowledge provided in the applied prior art, would have
been led to the subject matter recited in claims 1-7, 16, and 17 \vithin the
meaning of 35 U.S.C. § 103(a). Accordingly, we sustain the Examiner's
§ 103(a) rejections of these claims for the reasons set forth in the Final
Rejection and the Answer. We add the discussion below primarily for
emphasis and completeness.
Rejection 1
The Examiner has found, and Appellants do not dispute, that Williams
discloses random biodegradable polyhydroxyalkanoate (PHA) copolymers
containing multiple units of the following formula:
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... • ... ... ... -1 ' A ... ~ 1 ~,., ~1. ... ~A ... • ... ... , ... wnere n 1s prererao1y l to 4, ana K', K~, KJ, ana K' can eacn maepenaenuy
be selected from, inter alia, halogen, hydrogen, methyl, hydroxyl groups,
and carboxylic acid groups. (Compare Ans. 2 with App. Br. 3-7.) The
Examiner has also found, and Appellants do not dispute, that these random
polyhydroxyalkanoate (PHA) copolymers not only include repeat units
derived from one or more hydroxyacids containing 1 to 15 carbon atoms, but
also include functionalized repeat units derived from one or more a-
halogenated hydroxyacids or a-halogenated hydroxyalkonoate esters when
R3 or R 4 of formula I is halogen, i.e., halogenated at the a- (or carbon 2)
position. (Compare Ans. 2 with App. Br. 3-7.) Further, the Examiner has
found, and Appellants do not dispute, that Williams exemplifies a copolymer
of R-3-hydroxyoctanoic acid and R-3-hydroxyhexanoic acid, with the
disclosure of functionalizing such copolymer with halogens, such as bromo
groups. (Compare Ans. 2 with App. Br. 3-7.) Williams, like Appellants,
discloses that such halogenation provides sites for covalent attachment of
drugs to the polymer for the drug delivery purpose. (Compare Williams
col. 7, 11. 37-55 with Spec. iii! 3 and 27.)
Thus, based on these findings, the Examiner has concluded that one of
ordinary skill in the art, armed with the knowledge provided by Williams,
would have been led to the claimed functionalized biodegradable
copolyester within the meaning of 35 U.S.C. § 103(a).
Appellants contend that the "Examiner has failed to make a prima
facie case of obviousness, because the disclosure of a genus does not make
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obvious the species encompassed by the genus." (App. Br. 3.) Appellants
also contend that the Examiner has not identified an embodiment of
Williams that discloses or suggests using an a-halogenated hydroxyacid or
an a-halogenated hydroxyalkonoate ester to prepare an a-halogenated
polyester. (App. Br. 3-5.) In other words, Appellants contend that there is
no reason or suggestion in Williams to form random copolymer having the
recited functional repeat units. (Id.)
However, we find Appellants' arguments lacking in persuasive merit
because Williams' disclosure as a whole, would have led one of ordinary
skill in the art, through no more than ordinary skill and creativity, to random
polyhydroxyalkanoate copolymers having repeat units functionalized with
halogen groups at the alpha position, with a reasonable expectation of
successfully producing a polymer to which a drug could be covalently
attached for the drug delivery purpose. As acknowledged by Appellants, 3
the random polyhydroxyalkanoate copolymers having multiple units of
formula I (---OCR1R2(CR3R4)nCO-) disclosed in Williams are inclusive of the
copolyesters recited in claim 1 having repeat units derived from one or more
hydroxyl acids and repeat units derived from one or more a-halogenated
hydroxyacids. (App. Br. 3.) Specifically, when one of the repeating units in
3 When addressing the rejection of claims 1, 16, and 17 as unpatentable for
obviousness over Williams, Appellants state in their Appeal Brief that "the
disclosure of a genus does not make obvious the species encompassed by the
genus," acknowledging that Williams discloses a genus that encompasses
the claimed copolyesters. (App. Br. 3.)
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Williams' copolymer is a hydroxyl acid derivative (such as, for example,
when n is 1to15, and R1, R2, R3, and R4 are Hor methyl), and another of the
repeating units in Williams' copolymer is an a-halogenated hydroxyl acid
derivative (such as, for example, when R1 and R2 are Hor methyl, one of R3
and R 4 is halogen, and the other of R3 and R 4 is H or methyl), the resultant
copolymers comprise repeat units derived from one or more hydroxyacids
containing from 2 to about 20 carbon atoms, and repeat units derived from
one or more a-halogenated hydroxyacids, as recited in claim 1. In other
words, the polyhydroxyalkanoate copolymers having multiple units of
formula I disclosed in Williams can comprise halogen functional groups at
the a position, as recited in claim 1, and the claimed genus of copolyesters
thus overlaps with Williams' genus of random polyhydroxyalkanoate
copolymers. In addition, as discussed supra, Appellants do not dispute the
Examiner's finding that Williams exemplifies a copolymer of R-3-
hydroxyoctanoic acid and R-3-hydroxyhexanoic acid, 4 with the disclosure of
functionalizing such copolymer (one of the repeating units of the copolymer)
with bromo (halogen) groups in order to provide sites for covalent
attachment of drugs to the polymers. Although Williams teaches using its
copolymer for various biomedical purposes, it, like Appellants' invention,
indicates that incorporating the halogen functional groups to the copolymer
allows attachment of drugs or therapeutic molecules to the copolymers for
4 Paragraphs 7 and 52 of the Specification exemplify halogenating 3-
hydroxypropionic acid to provide a halogen at the a position.
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the drug delivery purpose. (Compare Williams col. 1, 11. 20-24 and col. 7,
11. 37-55 with Spec. i1i13 and 27 .)
Thus, we find no reversible error in the Examiner's determination that
the disclosures of Williams as a whole would have led one of ordinary skill
in the art, through no more than ordinary creativity, to the claimed
functionalized biodegradable copolyester, with a reasonable expectation of
successfully using it for the drug delivery purpose. Merck & Co., Inc. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) ("That the '813
patent discloses a multitude of effective combinations does not render any
particular formulation less obvious. This is especially true because the
claimed composition is used for the identical purpose."); In re Susi, 440 F.2d
442, 445 (CCPA 1971) (obviousness rejection affirmed where the disclosure
of the prior art was "huge, but it undeniably include[ d] at least some of the
compounds recited in appellant's generic claims and [was] ... of a class of
chemicals to be used for the same purpose as appellant's additives").
Appellants argue that the situation in In re Baird, 16 F.3d 380 (Fed.
Cir. 1994) is analogous to the present rejection because, according to
Appellants, formula I of Williams encompasses well over 100 million
options, and Williams does not specifically disclose a species of the claimed
copolyesters. (App. Br. 5-7.) However, we find the present situation to
differ markedly from that of Baird. Although the prior art applied in Baird
did disclose a genus that encompassed more than 100 million compounds,
only three of the claimed compounds were within the prior art genus and no
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guidance was provided toward the claimed compounds in the prior art.
Baird, 16 F.3d at 382. In contrast, as discussed above, in the present case,
the claims define a genus of copolymers that significantly overlaps with the
genus of polyhydroxyalkanoate copolymers disclosed in Williams.
Moreover, as indicated supra, Appellants do not dispute the Examiner's
finding that Williams exemplifies a copolymer of R-3-hydroxyoctanoic acid
and R-3-hydroxyhexanoic acid, with the disclosure of functionalizing such
copolymer with a limited number of functional groups, such as, halogen
groups, e.g., bromo groups, in order to provide sites for covalent attachment
of drugs to the polymers for the drug delivery purpose. Therefore, Baird is
not relevant to the present situation.
Appellants attempt to rebut the Examiner's prima facie case of
obviousness by arguing that the Specification sets forth the criticality5 of
halogenation at the a position. (Reply Br. 3--4.) Specifically, Appellants
argue that the Specification makes clear "that many functional groups do not
survive or would produce a side reaction during polymerization. If a
polymer is produced with an alpha halogen group, a functional group can
replace the alpha halogen post polymerization." (Reply Br. 3--4, citing Spec.
i-fi-16-7.) However, Appellants do not provide any evidence in support of
these assertions, and Appellants' mere arguments in the Reply Brief and
5 In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990)(explaining that
Appellants can evince the criticality of a novel feature of the claimed
invention, "generally by showing that the claimed [novel feature] ...
achieves unexpected results relative to the prior art" feature.)
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statements in the Specification cannot take the place of objective evidence.
In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984); In re Payne, 606 F.2d
303, 315 (CCPA 1979); In re Pearson, 494 F.2d 1399, 1405(CCPA1974).
Accordingly, on this record, Appellants have not identified reversible
error in the Examiner's determination that the subject matter of claims 1, 16,
and 17 would have been obvious in view of the disclosures of Williams, and
we accordingly sustain the Examiner's rejection of claims 1, 16, and 17
under 35 U.S.C. § 103(a) as unpatentable over Williams.
Rejection 2
Appellants do not dispute the Examiner's finding that Holmes
discloses copolymers comprised of 50 % to 99.9 % of repeat units of
formula I:
which correspond to the repeat units derived from one or more hydroxyi
acids recited in claim 1, and 0 .1 % to 50 % of repeat units of formula II:
in which n is 0 or 1, and R1, R2, R3, and R4 can each be a halogen atom.
(Compare Ans. 3--4 with App. Br. 7-8.) Nor do Appellants dispute the
Examiner's finding that ifR3 or R4 of formula II is a halogen atom, the
repeat units defined by formula II are halogenated at the a- (or carbon 2)
position, and correspond to the repeat units derived from one or more a-
halogenated hydroxyacids recited in claim 1. (Compare Ans. 3--4 with App.
Br. 7-8.) We also note that Holmes discloses that the copolymers are
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produced in microorganisms by cultivating the microorganism with an acid
substrate, and discloses that appropriate acids include 2-chloropropenoic
acid, which yields a copolymer in which the formula II component is
halogenated at the a position. (Holmes 9, 1. 29--10, 1. 5; 13, 11. 17-24; 14,
1. 25.)
Appellants argue that the situation in Baird is analogous to the present
rejection because, according to Appellants, the copolymer disclosed in
Holmes encompasses well over 100 million options, and the Examiner does
not identify any disclosure in Holmes of "a derivative utilizing a-
halogenated hydroxyacid." (App. Br. 7-8.) However, the present situation
differs markedly from that of Baird. As discussed above, although the prior
art applied in Baird did disclose a genus that encompassed more than 100
million compounds, only three compounds included within the prior art
genus were claimed and no guidance was provided in the prior art toward the
claimed compounds. Baird, 16 F.3d at 382. In contrast, in the present case,
the claimed copolyesters overlap substantially with the genus of copolymers
disclosed in Holmes, and Holmes, at page 14, line 25, exemplifies a
copolymer having repeating units functionalized with a halogen at the a
position as required by claim 1. Therefore, the present case is not a situation
like Baird in which only three of the claimed compounds are encompassed
by a vast prior art genus, without any guidance in the prior art towards the
claimed specific structure.
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Therefore, on this record, Appellants have not identified reversible
error in the Examiner's determination that the subject matter of claims 1-7,
16, and 17 would have been obvious in view of the disclosures of Holmes,
and we accordingly sustain the Examiner's rejection of claims 1-7, 16, and
17 under 35 U.S.C. § 103(a) as unpatentable over Holmes.
CONCLUSION
In view of the reasons set forth in the Final Action, Answer, and
above, we affirm the Examiner's§ 103(a) rejections of claims 1-7, 16, and
17.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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